ColostomyPhase 4NCT02223104
Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
A Phase 4 study testing Flexima Active and Sensura in people with Colostomy, run by BBraun Medical SAS at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- Flexima Active and Sensura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient is at least 18 years old
- patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches
- patient having a colostomy for at least 1 month
- patient using currently a one-piece flat ostomy appliance with closed or drainable bags
- patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches
- patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
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- patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days
- patient covered by social security
Who cannot join
- patient receiving or having received, within the last month, chemotherapy or radiotherapy
- patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin
- patient already participating in another clinical study or who have previously participated in this investigation
- pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
- Conditions
- Colostomy
- Being tested
- Flexima Active, Sensura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexima ActiveDevice
SensuraDevice
| Study group | Role | What they receive |
|---|---|---|
| Sensura | Active comparator | Ostomy pouch Receives: Device: Flexima Active |
| Flexima Active | Experimental | Ostomy pouch Receives: Device: Sensura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
The patient will evaluate the level of leakage under the skin protector after each removal of pouch.
A 4 scale level will be used:
- "no leakage under the skin protector",
- "leakage under the skin protector not soiling clothes",
- "leakage under the skin protector soiling clothes",
- "sudden and massive leakage under the skin protector".
Measured: Up to one day for closed pouches and up to two days for drainable pouches.
Secondary outcomes (5)
Assessment of the condition of peristomal skin
Measured: At V1 and V2 protocol visits (at day 0 and day 14)
Acceptability of each pouch
Acceptability is defined by those criteria:
Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance
Measured: At each protocol visit (day 0, day 14 and day 28)
Preference between Flexima® Active and Sensura®
Measured: At each protocol visits (at day 0, day 14 and day 28)
Assessment of the quality of life with Stoma-QoL questionnaire
Measured: At each protocol visits (at day 0, day 14 and day 28)
Adverse(s) Event(s)
Measured: At each protocol visits (at day 0, day 14 and day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223104
- Sponsor's protocol ID
- OPM-G-H-1301
- Status last verified
- Jul 2015
- First submitted
- 25 Oct 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
- ClinicalTrials.gov ID
- NCT02223104
- Acronym / sponsor ID
- OPM-G-H-1301
- Conditions
- Colostomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensura | Active comparator | Device: Flexima ActiveOstomy pouch |
| Flexima Active | Experimental | Device: SensuraOstomy pouch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patient is at least 18 years old
- patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches
- patient having a colostomy for at least 1 month
- patient using currently a one-piece flat ostomy appliance with closed or drainable bags
- patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches
Key exclusion criteria (5 listed)
- patient receiving or having received, within the last month, chemotherapy or radiotherapy
- patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin
- patient already participating in another clinical study or who have previously participated in this investigation
- pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexima Active | Device | Sensura |
| Sensura | Device | Flexima Active |
Primary outcome
Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
Time frame: Up to one day for closed pouches and up to two days for drainable pouches.
The patient will evaluate the level of leakage under the skin protector after each removal of pouch. A 4 scale level will be used: * "no leakage under the skin protector", * "leakage under the skin protector not soiling clothes", * "leakage under the skin protector soiling clothes", * "sudden and massive leakage under the skin protector".
5 secondary outcomes
Assessment of the condition of peristomal skin
Time frame: At V1 and V2 protocol visits (at day 0 and day 14)
Acceptability of each pouch
Time frame: At each protocol visit (day 0, day 14 and day 28)
Preference between Flexima® Active and Sensura®
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Assessment of the quality of life with Stoma-QoL questionnaire
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Adverse(s) Event(s)
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flexima Active and Sensura in people with Colostomy, run by BBraun Medical SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura. (time frame: Up to one day for closed pouches and up to two days for drainable pouches.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.